A multicenter open-label, single arm, phase IV clinical trial to evaluate the safety and efficacy of KRABEVA®/Abevmy® administered as per the prescribing information in patients with solid tumors.
Deenanath Mangeshkar hospital and Research Centre, off karve Road, Erandwane, Pune – 411004, Maharashtra, India Pune MAHARASHTRA
9850811449
drchetandeshmukh@gmail.com
Dr Subhash Gupta
All India Institute Medical Sciences
Department of Radiation Oncology,
Dr BRA IRCH, AIIMS, Ansari Nagar, New Delhi-110029
New Delhi DELHI
9268906040
drsubhashgupta72@gmail.com
Dr Prabrajya Narayan Mohapatra
Apollo Gleneagles Hospitals
Apollo Gleneagles Hospitals, Kolkata 58, canal circular road, Kolkata 700054. Kolkata WEST BENGAL
033-23203040
Prabrajan.Mohapatra@rediffmail.com
Dr Arun Rajagopal Warrier
Aster Medcity, Aster DM Healthcare Pvt Ltd
Aster Medcity, Aster DM Healthcare Pvt Ltd., Kuttisahib Road, Near Kothad Bridge, South Chittoor P.O., Cheranalloor, Kochi, Kerala – 682027, India Kozhikode KERALA
Deep Hospital, 481- Model Town, Ludhiana Punjab - 141002 Ludhiana PUNJAB
9779898339
dramit.meet@gmail.com
Dr Chandragouda Dodagoudar
Dr. B.L.Kapur Memorial Hospital
Dr. B.L.Kapur Memorial Hospital, Pusa Road, New Delhi-110005 New Delhi DELHI
9958450124
drchandragouda.dodagoudar@blkhospital.com
DrSushil Meshram
Govt. Medical College and Hospital
85-Department of Radiation Therapy and Oncology, Govt. Medical College and Hospital, Nagpur-440003,Maharashtra Nagpur MAHARASHTRA
7028966535
drsushilonco@gmail.com
Dr Mahesh Shivhar Rewadkar
Govt. State Cancer Hospital & Research Center, Aurangabad
Asst. Professor (Radiation Oncology)
Govt. State Cancer Hospital & Research Center
Near Civil Hospital, Aaam Khas Maidan,
Aurangabad – 431001 – Maharashtra, India Aurangabad MAHARASHTRA
9421375200
rewadkarmahesh04@gmail.com
Dr Rajnish Vasant Nagarkar
HCG Manavata Cancer Centre
HCG Manavata Cancer Centre, opposite Mahamarg Bus Stand, Mumbai Naka, Nashik – 422002 Maharashtra, India Nashik MAHARASHTRA
0253-2592666
drraj@manavatcancercentre.com
Dr Chirag Desai
Hemato Oncology Clinic Ahmedabad Pvt Ltd
Hemato Oncology Clinic Ahmedabad Pvt Ltd
B/S Occura Eye Hospital and Pandit Dindayal Auditorium,
Rajpath Club road, Off SG Road, Ahmedabad - 380054. Gujarat Ahmadabad GUJARAT
Kempegowda Institute of Medical Sciences Hospital and Research Center
Kempegowda Institute of Medical Sciences Hospital and Research Center,
K.R Road, V.V Puram Bengaluru-560004
Bangalore KARNATAKA
9886769060
ctoncokims@gmail.com
Dr Viraj Borgaonkar
Krupamayi Hospitals
Krupamayi Hospitals
“Akshayâ€, Opposite Youth Hostel,
Near Baba Petrol Pump, Railway Station Road,
Aurangabad-431001, Maharashtra, India
Aurangabad MAHARASHTRA
9225330004
viraj.oncosurg@gmail.com
Dr Ashish Joshi
Mumbai Oncocare Centre
Mumbai Oncocare Centre (Unit of Cellcure Cancer Centre Pvt. Ltd.), 2nd Floor, Majithia Apartments, God’s Gift Premises Co-op Society Ltd., S V Road, Irla, Vile Parle (W), Mumbai – 400056 Mumbai MAHARASHTRA
9167009042
ashjoshi44@mocindia.co.in
DrVikasL
Mysore Medical College and Research Institute
Department of Oncology, Mysore Medical College and Research Institute,K R Hospital, Irwin Road, Mysore-570001 Mysore KARNATAKA
9663099774
vikilaxman@gmail.com
Dr Minish Mahendra Jain
Noble Hospital Pvt Ltd
Noble Hospital Pvt Ltd.(Anex Hospital), 153, Magarpatta city road, Hadapsar, Pune-411013, Maharashtra Pune MAHARASHTRA
9823133390
minishjain009@gmail.com
DrShriram Kane
RST Regional Cancer Hospital and Research Centre
RST Regional Cancer Hospital and Research Centre,Tukdoji chowk, Manewada Road, Nagpur 440027, Maharashtra Nagpur MAHARASHTRA
100 mg per 4 mL single-use vial and /or 400 mg per 16 mL single-use vial administered as per the prescribing information
Comparator Agent
Not Applicable
Not Applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Males and non-pregnant, non-lactating females of age 18 years and above
2. Patients with indicated malignancies eligible to receive bevacizumab as per the prescribing information and judgement of the investigator
3. Adequate bone marrow, liver and renal function (judged by the investigator based on investigations at screening)
4. ECOG of 0, 1 or 2.
5. All women of child bearing potential (i.e., ovulating, pre-menopausal) should use at least 2 reliable forms of contraception during the trial.
ExclusionCriteria
Details
1. Patients with known hypersensitivity to bevacizumab or other drugs required as part of treatment regimen for the malignancy.
2. History or presence of serious non-healing wound or active ulcer or untreated bone fracture.
3. Presence of or history of severe haemorrhage hemoptysis within 3 months prior to bevacizumab administration; significant gastrointestinal bleeding; intracranial hemorrhage or significant pathological vaginal bleeding.
4. Presence or history of severe arterial or venous thrombotic or thromboembolic events within the 6 months prior to first dose of bevacizumab in the trial.
5. History of gastrointestinal fistula/abscess/perforation or other fistula.
6. Tumor location known to be in close contact with major vessels, especially NSCLC
7. Presence of incompletely healed surgical wound at the time of first dosing of bevacizumab in the study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Incidence, nature and severity of adverse events causally related to bevacizumab
Up to 6 months ( throughout the study)
Secondary Outcome
Outcome
TimePoints
1. Proportion of patients discontinuing Bevacizumab and/or chemotherapy /other cancer treatment due to adverse events related to bevacizumab.
2. Evaluation of efficacy parameters such as Progression Free Survival (PFS), Time to progression (TTP), Disease Control Rate (DCR), overall response rate (ORR), Duration of Response (DR)
Up to 6 months
Target Sample Size
Total Sample Size="225" Sample Size from India="225" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="116"
This
is a multicentre, single arm, open label phase IV study to evaluate the safety
and efficacy of bevacizumab(KRABEVA® / Abevmy® )intravenous infusion administered as per the prescribing
information. The study will consist of a 21-day screening period, study drug
treatment cycles every 2 weeks or 3 weeks, lasting for a period of up to 6
months. Approximately 225 patients will be enrolled. The study population
will comprise of the patients with solid tumors who have passed screening
assessments, have provided written informed consent and considered
eligible to receive bevacizumab treatment as per the prescribing information of
bevacizumab as per the investigator. The patient will continue to receive
bevacizumab for a maximum period of 6 months after initiation of bevacizumab,
or until disease progression, death, unacceptable toxicity or withdrawal due to
any cause, whichever is earliest .During the study the safety assessments will
be conducted at recommended intervals as in the schedule of assessments. Patients
who meet the inclusion/exclusion criteria will be included in the study. The
patients will receive bevacizumab intravenous infusion (dosage range of 5 mg/kg
to 15 mg/kg body weight) in every 2 weeks or every 3 weeks cycles with or
without background chemotherapy or other cancer treatment as specified for
respective indications in the prescribing information of bevacizumab and/or as
per the standard practice of the site followed by the investigator. Recommended
efficacy assessments include CT scan/MRI, chest X-ray and any additional scans
required for assessment of disease status of the patient. These may be
performed at the visits recommended in the schedule of assessments (per the
NCCN guideline recommendations for the specific indications) and / or as per
the site standard practice